Various prosthetic mesh materials have been proposed to reinforce the abdominal wall and to close abdominal wall defects. In certain procedures, including incisional and umbilical hernia repair and chest reconstruction, the prosthetic mesh may come into direct contact with the sensitive abdominal viscera. Postoperative adhesions between the mesh and the intestine-may occur, potentially leading to intestinal fistulization.
Various approaches to reducing the incidence of postoperative adhesions arising from the use of prosthetic mesh materials have been proposed by the prior art. It has been suggested to cover the prosthesis with peritoneum or other tissue, where available or adequate to close the defect, to form a biological barrier between the implant and the bowel. Also proposed has been the placement of a physical barrier between the surgical site and the surrounding tissue where adhesions are most commonly encountered.
U.S. Pat. No. 5,002,551 discloses a physical barrier formed of a knitted oxidized regenerated cellulose (Intercede(TC7)). The patent indicates that other physical barriers include silicone elastomers and absorbable gelatin films. Clinical studies of Interceed(TC7) were reported in "Prevention of Postsurgical Adhesions by Interceed(TC7), An Absorbable Adhesion Barrier: A Prospective, Randomized Multicenter Clinical Study", Fertility and Sterility, Vol. 51, No. 6, June 1989, pg. 93-938. Such physical barriers alone are not sufficient to reinforce the abdominal wall or to repair abdominal wall defects.
Jenkins et al., "A Comparison of Prosthetic Materials Used to Repair Abdominal Wall Defects", Surgery, Vol. 94, No. 2, August 1983, pg. 392-398, describes a technique of placing an absorbable gelatin film (Gelfilm.RTM.) freely between a piece of Marlex.RTM. knitted polypropylene monofilament mesh and the abdominal viscera. The gelatin film dissolved after one week. Thereafter, the incidence of adhesions was reported to be the same as with using the Marlex mesh alone.
Accordingly, the prior art lacks a prosthesis suitable for abdominal wall reconstruction and ventral hernia repair which combines the strength and pliability of a prosthetic mesh with the low incidence of postsurgical adhesions of a physical barrier.